GMP Training for Operators

The GMP Training for Operators Course can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite or online virtual course for an agreed number of delegates from your site.

The GMP Training for Operators is a useful course for packaging and manufacturing organisations, both for new staff or those requiring a refresher.

The course is designed to minimise the operators’ time away from the workplace. Within the half day course, the important basics are covered through interaction and operator involvement.

This course can be delivered on-site for maximum benefit, providing the option of covering two sets of operators over one day. The training is also available as an open course delivered in hotels.

• Consider why GMP is so important for patients, healthcare regulators and manufacturers 
• Discuss and explain what GMP means
• Clarify the consequences of non-compliance to GMP for patients, regulators and subsequently the healthcare manufacturer
• Review of regular non-compliance problems e.g. labelling, contamination, not following procedures, missing documents etc.
• Briefly introduce who the main regulators are and the rules and regulations that healthcare manufacturers have to follow
• Learn and understand what standard operating procedures (SOPs) are and why they must be strictly followed and used during manufacturing and packaging
• Review of an SOP, why it is important to be trained against and used daily by operators in key critical tasks
• Keeping training records up-to-date
• Determine the effects of and differences between micro-biological contamination, cross contamination and foreign contamination
• A description of three types of contamination and what it means for operators, including the importance of clearing and cleaning between product changes
• Review of personal hygiene and gowning-up procedures and requirements
• Analyse the importance of good documentation practice and recall why it is so important
• Review examples of good documentation practice against poor practice
• Highlight the need for traceability when problems with product occur

This course can be delivered to a group of up to 12 delegates at your premises or as an online virtual classroom course for an agreed number of delegates from your site. Request a quote.

"Well delivered and open to questions with good answers.”
Bayer CropScience

“Very informative.”
Briar Chemicals Ltd

“It gives a good understanding of GMP.”
Briar Chemicals Ltd

“Helpful.”
Briar Chemicals Ltd

“It is a good overview of what is needed to know.”
RMS Innovations (UK) Limited

“Worth the journey.”
RMS Innovations (UK) Limited

“Informative and professional.”
Synergy Health plc

“Lots of info in an easy to understand, relaxed style.”
Synergy Health plc

“Concise and thorough balance.”
Synergy Health plc

“Informative.”
Bioquell UK Ltd

“Speaker is knowledgeable.”
Bioquell UK Ltd

“Good course and instructor.”
Briar Chemicals Ltd

ITS’ Regulatory Compliance Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).

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